A Study of Oral Contraception Under Simulated OTC Conditions



Status:Terminated
Conditions:Contraception, Contraception
Therapuetic Areas:Reproductive
Healthy:No
Age Range:12 - Any
Updated:2/27/2019
Start Date:April 27, 2018
End Date:November 14, 2018

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A Multi-Center Oral Contraceptive Pill Use Trial Conducted In an OTC Naturalistic Environment (OPTION)

This study is designed to assess whether consumers select and use norgestrel 0.075 mg, a
progestin only pill for contraception, in a manner consistent with the OTC package directions
in an Over-the-Counter (OTC)-like setting.

Subjects will be primarily recruited via passive recruiting methods, such as in-store
posters, direct mail postcards, and digital space advertising.

Respondents to advertisements will either call Clinical Research Organization (CRO) call
center or visit the study website for initial screening (during which data regarding age,
gender, and minimal study exclusion criteria will be collected) and scheduling of an
in-person enrollment visit at a local participating research site.

During the face-to-face enrollment visit, potential subjects who meet the inclusion and
exclusion criteria for the study will be given an (empty) study medication package and will
be allowed as much time as they need to review the information on the outside of the entire
package. Subjects will then be asked if the product is OK or not OK for them to use.

Qualified subjects then will be allowed to purchase (pharmacy sites) or be given (clinic
sites) the study product.

Approximately 47 sites will be used, comprising retail pharmacy research sites and women's
health clinics or adolescents' clinics.

Inclusion Criteria:

-Women who are willing purchase (in the pharmacies) or be provided (in the clinics) oral
contraception for their own use for the purposes of the study

Exclusion Criteria:

- Cannot read, speak and understand English

- Cannot see well enough to read information on the label
We found this trial at
41
sites
Homewood, Alabama 35209
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Homewood, AL
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Albuquerque, New Mexico 87104
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Albuquerque, NM
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Amery, Wisconsin 54001
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Amery, WI
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Anoka, Minnesota 55303
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Anoka, MN
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Bethlehem, Pennsylvania 18015
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Bethlehem, PA
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Birmingham, Alabama 35215
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Birmingham, AL
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Bountiful, Utah 84010
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Bountiful, UT
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Bridgeport, Connecticut 06606
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Bridgeport, CT
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Burlington, North Carolina 27215
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Burlington, NC
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Catonsville, Maryland 21228
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Catonsville, MD
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Clarksville, Tennessee 37043
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Clarksville, TN
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Cleveland, Tennessee 37311
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Cleveland, TN
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Dalton, Georgia 30721
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Dalton, GA
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Downey, California 90241
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Downey, CA
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Elk River, Minnesota 55330
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Elk River, MN
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Elsberry, Missouri 63343
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Elsberry, MO
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Enumclaw, Washington 98022
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Enumclaw, WA
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Fridley, Minnesota 55432
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Fridley, MN
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Griffin, Georgia 30224
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Griffin, GA
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Hartford, Connecticut 61121
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Hartford, CT
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Houston, Texas 77008
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Houston, TX
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Kenmore, Washington 98028
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Kenmore, WA
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La Habra, California 90631
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La Habra, CA
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Long Beach, California 90806
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Long Beach, CA
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Los Angeles, California 90005
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Los Angeles, CA
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Manchester, Missouri 63088
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Manchester, MO
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Mapleton, Utah 84664
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Mapleton, UT
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McCalla, Alabama 35111
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McCalla, AL
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Monroe, New Jersey 08831
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Monroe, NJ
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Montpelier, Virginia 23192
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Montpelier, VA
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New Haven, Connecticut 65111
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New Haven, CT
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Riverview, Florida 33578
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Riverview, FL
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Saint Francis, Minnesota 55070
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Saint Francis, MN
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Savannah, Missouri 64485
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Savannah, MO
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Seattle, Washington 98122
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Seattle, WA
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Sherman, Texas 75092
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Sherman, TX
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Snohomish, Washington 98290
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Snohomish, WA
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South Charleston, Ohio 45368
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South Charleston, OH
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Springfield, Missouri 65807
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Springfield, MO
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Syracuse, Utah 84075
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Syracuse, UT
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Tucson, Arizona 85704
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Tucson, AZ
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